MAUDE Adverse Event Report: JACE MEDICAL T15 HEXALOBE DRIVE SILVER; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	201.047.15
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) g2: foreign - event occurred in japan.A visual inspection was conducted on the driver, which shows signs of multiple uses including very heavy marking and scratching on the driver surface and also shows signs of wear from use.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The reported event is confirmed through product return.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that a driver was worn but was discovered to be fractured post investigation.There was no patient involvement.Attempts have been made and no further information has been provided.

• Brand Name: T15 HEXALOBE DRIVE SILVER
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): JACE MEDICAL; 3516 commerce drive; warsaw IN 46580
• Manufacturer (Section G): JACE MEDICAL; 3516 commerce drive; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23554292
• Report Number: 3010906386-2025-00002
• Device Sequence Number: 18670599
• Product Code: HWR
• UDI-Device Identifier: 00851599007655
• UDI-Public: (01)00851599007655(10)1122203
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 201.047.15
• Device Lot Number: 1122203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown